Note: The job is a remote job and is open to candidates in USA. Eli Lilly and Company is a pharmaceutical company developing and delivering life-changing medicines, including through its wholly owned subsidiary Centessa Pharmaceuticals. The Senior Clinical Data Manager will lead clinical data management activities for global development programs, overseeing data systems, standards, vendors, documentation, quality, and regulatory compliance. The role partners with cross-functional teams to deliver reliable clinical data supporting development milestones and regulatory submissions.
Responsibilities
- Lead the planning and execution of clinical data management activities to support global development programs, ensuring high‑quality, timely, and cost‑effective delivery
- Develop and oversee data management strategies and plans, including data capture tool design, data processing, coding, validation, and ongoing data quality oversight
- Establish and maintain clinical data systems and infrastructure, including the identification, set‑up, testing, and technical oversight of electronic clinical trial technologies (e.g., EDC, IRT, ePRO, ECG, and other external data sources)
- Drive data standards strategy and compliance, providing guidance across the data continuum and ensuring adherence to CDISC/CDASH standards to support regulatory submissions
- Partner closely with internal stakeholders and external CRO and technology vendors to align on requirements, timelines, deliverables, and performance expectations
- Provide oversight of vendor technology platforms and processes, ensuring they meet regulatory, quality, and inspection‑readiness requirements for global development programs
- Develop and manage data management documentation, including data management plans, data transfer plans, and validated automated data flows for internal and external data
- Monitor timelines, milestones, and deliverables, proactively communicating risks, metrics, and status to cross‑functional teams and leadership
- Generate and review in‑process data reports and listings to support trial oversight and decision‑making, including safety and data review activities
- Provide data management input into clinical and regulatory documents, including protocols, protocol amendments, clinical study reports, and statistical analysis plans
- Ensure data integrity, quality, and regulatory compliance, supporting GCP inspection readiness across all data management domains
- Contribute to the development of best practices, SOPs, and scalable data management processes to support a growing clinical portfolio
Skills
- • Bachelor's or Master's degree with a minimum of 6+ years of hands‑on clinical data management experience in a pharmaceutical or biotechnology environment
- • Qualified applicants must be authorized to work in the United States on a full-time basis
- • Expert knowledge of electronic clinical data systems, including multiple vendor EDC platforms and related clinical trial technologies
- • Proven experience managing and partnering with CROs and technical vendors, including oversight of deliverables, timelines, and quality
- • Strong understanding of regulatory requirements impacting clinical data management, including experience supporting regulatory submissions; Pre‑IND, IND, NDA, and/or BLA experience strongly preferred
- • Demonstrated experience supporting multiple complex clinical studies, including early‑phase (first‑in‑human and proof‑of‑concept) trials; Phase I–III experience preferred
- • Excellent project planning and organizational skills, with the ability to prioritize competing demands, manage timelines, and deliver high‑quality work in a fast‑paced environment
- • Highly self‑motivated and detail‑oriented, with strong analytical skills, intellectual curiosity, and a proactive approach to problem solving
- • Exceptional interpersonal, communication, and presentation skills, with the ability to influence and collaborate effectively across cross‑functional teams and with external partners
- • Strong critical and strategic thinking abilities, enabling effective analysis of complex data and operational challenges
- • The Senior Clinical Data Manager role is a based in the US, with occasional travel
- Pre‑IND, IND, NDA, and/or BLA experience strongly preferred
- Phase I–III experience preferred
Benefits
- Company bonus, depending in part on company and individual performance
- Eligibility to participate in a company-sponsored 401(k)
- Pension
- Vacation benefits
- Eligibility for medical, dental, vision and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities
- Employee resource groups offering strong support networks for their members
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